Document reL6GxakQ153eGeQddEmY51nq

FILE NAME: Johnson & Johnson (JAJ) DATE: 1974 Jan 18 DOC#: JAJ025 DOCUMENT DESCRIPTION: Memo RE Talc/Asbestos - Meeting with Commissioner Schmidt, FDA Jan 16 1974 I ? 4- i c Subject: T alc/A sbestos M eeting with C om m issioner Schmidt FDA J a n u a ry 16, 1974 2044 Wew Brunswick, N .i. J a n u a ry 18, 1974 Memo to F ile A tten d ees: for FEA: D r, V. W odicka,D irector, Bureau of Foods D r. H. E ierm a n n ? D irecto r) D ivision of C osm etics Technology. M r. J . W enninger, Deputy D irecto r, D ivisionof C osm etics Technology. L ater: C om m issioner Schm idt and the above. for J& J: D r. R. F u ller, D r. G. HUdick-Smith, D r.W .N ashed A p relim in ary m eeting with D r. Wodicka and his staff was held. We tra c e d the h isto ry of the ta lc /a s b e s to s problem : K retch m er le tte r; FDA Sym posium , August, 1971, w here Mt. S inai people adm itted that their analysis based on optical m icroscopy of our product was wrong and that Johnson it Johnson Baby Pow der was the best talc available; and we m entioned the voluminous data which we had sh ared with the FDA. D r. E ierm ann and M r. W enninger .co rro b o rated our presen tatio n s to Dr.- W odicka. D r. E ierm an n then said that he has review ed the CTFA Round-Robin te st re su lts with his m icroscopist, M r. Schulze, and said that M r. Schulze s till thinks the m ethod is v alid . We pointed out th at we believe that the method has som e basic flaws as outlined in the CTFA comment-, how ever, we believe that a cooperative program between FDA and industry should re su lt in a p ra c tic a l solution to the problem . 3 F o rm e r JfcJ em ployee in B ra z il. Protected D ocum ent-a**" Protective order' J&J-0132008 JNJMX68JM0017147 ) l.. M emo to F ite 2 2045 Jan u ary 18, 1974 We pointed out th at we had developed a DTA m ethod capable of m e a s u rin g 1% c h ry so lite and we a ls o b eliev e th a t a ste p sca n x-raym ethod c a n be used to d e te c t 0 . 2% tr e m o lite . D r. E ierm ann said that they have obtained DTA equipm ent and x -ra y equipm ent and that he has som e re se rv a tio n about allowing 1% c h ry s o tile . We v o lu n teered to cooperate with his s c ie n tists in the developm ent of the m ethod for DTA and prom ised to provide a copy of a proposed publication regarding this method. D r. E ierm ann said that his m ain in te re st a t th is tim e is to find what lev el of dust exposure occurs in the p rocess of dusting a baby and th a t they would like to use the d a ta to c a lc u la te allow able a s b e s to s using 5 fib e rs p e r m l (OSHA lim it) fo r sa fe ex p o su re in' the m in es. We prom ised to provide a re p o rt on the talc dust e x p o su re of b a b ie s. We pointed out th a t the d ata we have is based on exaggerated dusting of a whole can of baby pow der and that the am o u n t g e n e ra te d , nam ely 345 mg/ rn^ m ay be e x c e ssiv e . We said th at we a r e c u rre n tly attem pting to m ake the sam e calculation he p ro p o se d to the data.ijiir v e ry p reU r in d ic a te s th a t su b sta n tia l asb e ito V cati fra allow ici - safely in a baby P o w der. D r. W odicka appeared skeptical of D r. E ierm an n 's approach to the p ro b le m . Jjfe im p lie d that wha* is s a f e for a m in e r m ay not be safe fo r a bfdsy.: D r. E ierm ann also mentioned that they w ere carrying out some studies in-house using an a ir sam pler to a s s e ss the dust exposure and w ere having some difficulties in determ ining it. D r. H lldick-Sm ith review ed the cu rren t knowledge on the biology of ta lc and indicated that talc had a low o rd e r of toxicity when evaluated in cell culture system s, that anim al studies had been conducted w hich co n firm ed the cel.1 c u ltu re s tu d ie s , and th at longra n g e in h a la tio n stu d ie s in r a ts by MRC and in h a m s te rs by J b J w ere being conducted in England ai.d in the U .S, A. and that the re s u lts w ill be av ailab le in 1975. It w as pointed out th at two se p a ra te epidem iological studies had been conducted on talc m iners, one by D r. K leinfeld and the o th er by D r. G reen a t the U niversity of V erm ont School of M edicine i n Burlington. The data obtained from both studies indicated that, w here m iners in the K leinfeld study had been exposed to ta lc d u st fo r an av erag e of about 17 y e a rs and in the G reen study for about 7 years, there appeared to be no significant im pairm ent of the m in e rs' health. Utilizing these data, the known inform ation Protected Document-Subject to Protective Order J&J-0132009 JNJMX8_000017146 i f * - Memo to File 3 Ja n u a ry 18. 3974 2046 concerning the am ount of talc to which infants w ere exposed and th eir re sp irato ry capacity, m iners w ere exposed for a period of approxim ately 1, 000 tim e s th at of an in fan t. The d o se re s p ir e d by the m in e r is ap p ro x im ately 11, 000 tim e s that re s p ire d by the infant. It w as brought out that c ritic a l review of a ll the w orld lite ra tu re failed to show any evidence of adverse health effects following the norm al use of cosm etic talcs. D r. H ildick-Sm ith indicated that he was w riting a review artic le on talc and that a copy of the m an u scrip t would be sen t to the FDA for th e ir flies. Dxw^Fvllar stre sse d Johnson b John so n 's policy o ffu ll cooperation with Kti'A. and th a t i f this r e s u lts o f a n y s c ie n tific s tu d ie s show any q u estio n o f safety o f talc, Johnson % Johnson w ill not hesitate to take it off the m arket. A m eeting was then held in D r. S chm idt's office. The proceedings w ere sim ila r to that which took place in Dr. W odicka's office . D r. Schm idt asked [or inform ation on our V erm ont m ine: location (W indsor, V t.J, kind of talc {platey talc), processing (froth flotation to m axim ize platey talc). He wanted to know w hether we sell our talc to other com panies (cosm etic beneficiated grade is not sold to other com panies; other locations in the W indsor mine a re used to supply industrial grade talc). D r. F u lle r pointed out that our m eeting is not a " c ris is " m eeting. The C om m issioner appeared to ap p reciate that. D r. F u ller again s tre s s e d Johnson ti Johnson's pplicy of full cooperation with the FDA which preceded the K retchm er incident, nam ely, the Tenovus re p o rt w here D r. H ildick-Sm ith had called D r, Sim m ons at the tim e we first heard of it. We review ed b riefly the Tenovus data (u n reliab le talc p article identification technique, p resen ce of m in eral p articles in die tissue-fixing baths, lack of form al education of the principal investigator). D r. H ildick-Sm ith also com m ented b rie fly on the a rtic le relating stom ach cancer in the Japanese and pointed out that this was generally discredited by scien tists and that th ere was no inform ation in the w orld lite ra tu re or in anim al studies com pleted to indicate talc produced cancer. D r. Schm idt said that the FDA could com e under p re ssu re 'fro m consum er or other groups and that they w ere p artic u la rly vulnerable when there w ere m in im a l, inadequate o r no s c ie n tific data in a sp ec ific a r e a . He had, however, developed a tactic by w hich he publishes in the F ed e ra l R egister any scientific attack on the FDA in the hope that m em bers of the scientific com m unity could provide data to a s s is t the FDA. Protected Document-Subject to Protective Older J&J-0132010 JNJMX68_000017149 > .3 ' ) M emo to F ile 204 -4 Ja n u a ry 18, 1^74 He ap p reciated the Johnon it Johnson v isit and our ex p ressio n of in te re st to a s s is t the FDA where possible. He welcomed the opportunity of having a source of scientific inform ation on which he could rely if the o c c a sio n a n t e . .He in d icated the im m e d ia te i n t e r e s t of th e FDA in developing a method fo r a sse ssin g asb esto s in talc.. He pointed out th a t a d d itio n a l in fo rm atio n being developed by Jo h n so n It Jo h n so n and o th e rs would m eet the possible future need if talc p e r se is attacked. A s th e r e w ere som e scien tific data and good'sc ie n tific stu d ie s in.hand, the scien tific community would be w ell p repared to w ithstand any on slaught concerning talc. It T he m e e tin g ended on a v e ry c o r d ia l note and a p p re c ia tio n by the FDA officials of Johnson Johnson's v isit and w illingness to cooperate with the agency in developing methods and providing inform ation concerning talc technology. cc: D r. R. A. Fulter D r. A. Qoudic D r. G. Hildick-Smith M r. D. D. Johnston M r. G. Lee D r. D. F e tte r son M r. S. Smoyer D r. T. Shelley M r. H. Stolaer C W. N ashed Protect! Document-Subject to Protective order J&J-0132011 JHJMXMJW0017160